Dialysis Center of Athens

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 50523 Based on observation, staff interviews, a review of the manufacturer’s Directions for Use (DFU), a review of facility Policies and Procedures (P&P), and a review of the Association for the Advancement of Medical Instrumentation’s (AAMI’s) “American National Standard for Dialysate for Hemodialysis” (ANSI/AAMI RD52: 2004), it was determined that the facility failed to ensure that there was a safe environment for all in-center hemodialysis (ICHD) patients as evidenced by failure of two of two Patient Care Technicians (PCTs - PCT AA and PCT BB) observed, to correctly verify the hemodialysis (HD) machine’s final dialysate conductivity (ability of the dialysate to conduct electricity) and pH (acidity), according to the manufacturer’s DFU and facility’s P & P. This failure had the potential to negatively affect the health and safety of five of five patients who were receiving hemodialysis treatment at Stations (S) 1, S2, S4, S6, and S7 at the time of observation. Incorrect dialysate composition can lead to a range of complications, from mild symptoms such as nausea and fatigue to more serious conditions like metabolic acidosis (a decrease in blood pH that may cause rapid breathing, confusion, dizziness, shortness of breath, or chest pain). And if conductivity is out of the acceptable range, the effectiveness of the dialysis treatment may be reduced, and impair patient treatment, alter electrolyte and fluid balance, and lead to serious health consequences. The facility census was 10. Findings include: Cross Reference: V 250 - Failure of PCT AA and PCT BB to correctly verify the machine’s final dialysate conductivity and pH according to the manufacturer’s DFU and facility P & P.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 50523 Based on observations, staff interviews, a review of facility records, a review of the manufacturer’s Directions for Use (DFU) and a review of facility Policies and Procedures (P & P), it was determined that the Governing Body failed to demonstrate responsibility and accountability for the operations of the facility. This failure had the potential to negatively affect the health and safety of 10 in-center hemodialysis patients who dialyzed at this facility. Findings include: Cross References: V 250 - Failure of the facility to ensure that two of two Patient Care Technicians (PCT AA and PCT BB) observed, correctly verified the machine’s final dialysate conductivity (ability of the dialysate to conduct electricity) and pH (acidity), according to the manufacturer’s DFU and facility P & P. V 715 - Failure of the Medical Director to ensure that one of one Registered Nurse (RN AA) adhered to facility P & P relative to pre-dialysis assessment; and failure of the Medical Director to ensure that five of five patients (P) (P#1, P#2, P#3, P#4, and P#5 sampled, had a prescription for dialysis composition of bicarbonate value, for the Direct Patient Care (DPC) Staff (nurses and patient care technicians) to follow during each patient’s hemodialysis treatments.”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 50523 Based on observation, staff interviews, and a review of the American Heart Association (AHA) recommendations, it was determined that the facility failed to ensure that expired supplies in one of one Emergency Crash Cart, were removed and not made available for use, and re-supplied in order to be in a ready-to-operate condition. This deficient practice had the potential to negatively affect the health and safety of 10 in-center hemodialysis patients who were under the care of this facility. Findings include: During a tour in the Patient Treatment Room on 7/21/25 from 9:56 a.m. through 10:32 a.m., the following supplies had expired, thus these were not suitable for use. In the Emergency Crash Cart: - Two of two pads used for an Automatic External Defibrillator (a portable device that analyzes heart rhythm and delivers an electric shock to restore a normal rhythm during cardiac arrest), expired 3/20/24 and 4/5/25 respectively, therefore it was not in a ready-to-operate condition. - On 7/21/25, Registered Nurse (RN AA) , who was also the Charge Nurse, acknowledged these findings at 10:15 a.m. -According to AHA recommendation, AED pads should be replaced before their expiration date. Expired pads may not adhere properly to the skin, and their adhesive gel can dry out, making them ineffective in delivering a life-saving shock.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 50523 Based on observation, staff interviews, a review of the manufacturer’s Directions for Use (DFU), a review of facility Policies and Procedures (P&P), and a review of the Association for the Advancement of Medical Instrumentation’s (AAMI’s) “American National Standard for Dialysate for Hemodialysis” (ANSI/AAMI RD52: 2004), it was determined that the facility failed to ensure that there was a safe environment for all in-center hemodialysis (ICHD) patients as evidenced by failure of two of two Patient Care Technicians (PCTs - PCT AA and PCT BB) observed, to correctly verify the hemodialysis (HD) machine’s final dialysate conductivity (ability of the dialysate to conduct electricity) and pH (acidity), according to the manufacturer’s DFU and facility’s P & P. This failure had the potential to negatively affect the health and safety of five of five patients who were receiving hemodialysis treatment at Stations (S) 1, S2, S4, S6, and S7 at the time of observation. Incorrect dialysate composition can lead to a range of complications, from mild symptoms such as nausea and fatigue to more serious conditions like metabolic acidosis (a decrease in blood pH that may cause rapid breathing, confusion, dizziness, shortness of breath, or chest pain). And if conductivity is out of the acceptable range, the effectiveness of the dialysis treatment may be reduced, and impair patient treatment, alter electrolyte and fluid balance, and lead to serious health consequences. The facility census was 10. Findings include: During observation in the Patient Treatment Room on 7/23/25 between 5:00 a.m. and 6:40 a.m., the following was revealed: - At 5:10 a.m., PCT AA was observed entering the Dialysate Preparation room to obtain the Myron L Ultrameter II 6P (a portable, multi-parameter water quality meter, used to measure conductivity, pH...). - PCT AA was observed at 5:14 a.m., verifying the machine’s final dialysate conductivity and pH at S7, using the Myron L Ultrameter II 6P. PCT AA obtained a dialysate sample from the machine and proceeded to fill the Ultrameter with the sample once, then immediately read the results. - PCT AA was observed at 5:27 a.m., verifying the machine’s final dialysate conductivity and pH at S16, using the Myron L Ultrameter II 6P. PCT AA repeated the same incorrect procedure as mentioned above. - PCT BB was observed at 5:30 a.m., verifying the machine’s final dialysate conductivity and pH at S2, using the Myron L Ultrameter II 6P. PCT BB obtained a dialysate sample from the machine and proceeded to fill the Ultrameter with the sample twice, then immediately read the results. -During an interview on 7/23/25 at 6:00 a.m. PCT BB stated that, depending on whether the Ultrameter readings were out of range, she might have used multiple samples; however, she usually used only two samples before reading and recording the pH and conductivity results. -During an interview on 7/23/25 at 6:35 a.m., PCT AA stated that she typically collected a sample and filled the Ultrameter twice before reading the results. PCT AA also stated that the facility used the same Ultrameter to check the Bicarbonate levels prior to the first patient treatment. -A review of the manufacturer’s DFU on the “Myron L Ultrameter (Trademark) II 6P”, showed the following: Page 9-10 V. SPECIFIC RECOMMENDED MEASURING PROCEDURES A. Measuring Conductivity & Total Dissolved Solids (TDS) 1. Rinse cell cup 3 times with sample to be measured. (This conditions the temperature compensation network and prepares the cell.) 2. Refill cell cup with sample. 3. Press COND or TDS. 4. Take reading. C. Measuring pH (6PFCE) 1. Remove protective cap by rotating while grasping and pulling up. 2. Rinse pH/ORP sensor well and conductivity cell cup 3 times with sample to be measured. Shake out each sample to remove any residual liquid. 3. Refill both sensor well and cell cup with sample. 4. Press pH. 5. Note value displayed -Failure to properly rinse the Myron L Ultrameter II 6P prior to checking the dialysate pH and conductivity can lead to inaccurate readings from the residue from the bicarbonate mixed with the dialysate, which can result in false high or low readings for both pH and conductivity. A review of facility Policy: E-Tec-203 titled, “Ultrameter (Trademark) Model 6P Procedure”, stated: 5. Procedure A. Daily Use- Dialysate Testing 1. Rinse the Ultrameter’ s conductivity and pH sensors three (3) times using dialysate from the blue Hanson port of the dialysis machine. 2. Refill the sensor with the dialysis. 3. Press COND to measure conductivity. 4. Press pH to measure dialysate pH. According to ANSI/AAMI RD52: 2004, Section 5.6, “Dialysate Proportioning”, it is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. - The Director of Operations (DO) was notified of the above findings on 7/23/25 at 7:18 a.m.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 50523 Based on medical record review, including a review of facility Policy and Procedures (P&P), and staff interview, it was determined that the facility failed to ensure that three of five in-center hemodialysis (ICHD) patients (P) (P#1, P#2, and P#3) sampled, had a patient Plan of Care (POC) that reflected timely, collaborative participation of all members of the Interdisciplinary Team (IDT), including the patient or patient’s representative. Failure to facilitate discussion and coordination among IDT members about the information gathered from the patient’s comprehensive interdisciplinary assessment in a timely manner could result in delayed development/implementation of the patient’s POC and delayed achievement of the desired goals. This deficient practice had the potential to negatively affect the health and safety of P#1, P#2, and P#3 and the other seven ICHD patients who were under the care of this facility. Findings Include: During a review of P#1’s, P#2’s and P#3’s medical records, the following was revealed: - P#1 was admitted on 12/21/24. The Annual Care Plan was dated 3/21/25. The Social Worker’s (SW’s) signature was dated 3/21/25. The Registered Nurse’s (RN’s) signature was dated 4/14/25. The Registered Dietician’s (RD’s) signature was dated 7/21/25. The nephrologist’s signature was on 7/21/25. P#1’s or his representative’s signature was missing. - P#2 was admitted on 4/1/21. The Annual Care Plan was dated 3/3/25. The SW’s signature was dated 3/3/25. The RN’s signature was dated 4/14/25. The RD’s signature was dated 7/21/25. The nephrologist’s signature was dated 7/21/25. P#2’s or her representative’s signature was missing. - P#3 was admitted on 4/1/21. The Annual Care Plan was dated 2/28/25. The SW’s signature was dated 2/28/25. The RN’s signature was dated 4/7/25. The RD’s signature was dated 7/21/25. The nephrologist’s signature was dated 7/21/25. P#3’s or his representative’s signature was missing. - P#1, P#2, and P#3 were diagnosed with End Stage Renal Disease (ESRD) and were receiving hemodialysis treatment three times per week. There was no documentary evidence that all three patients or their representatives were included in the development nor discussion of their Annual Care Plan, as required. Though the IDT provided signatures, their uncoordinated timing could have led to missed interventions due to gaps in communication for issues like poor nutrition status, fluid overload, psychosocial concerns, medication management affecting treatment outcomes and patient adherence. A review of facility Policy: (no number), titled, “Monthly/ Long term Careplans”, (no effective/revision dates), stated: 3. The careplans will be reviewed with the patient and the patient will sign the careplan after review. A review of facility Policy: (no number), titled, “Plan of Care”, (no effective/revision dates), stated: 2. Team Involvement: The interdisciplinary team may include the patient’s nephrologist, nurse, dietician, social worker, and the patient or their representative. 3. Updates may be documented separately by discipline to allow for: 1. Clinical accuracy 2. Real- time documentation 3. IDT scheduling flexibility Final review and acknowledgement must occur within 30 days of the earliest entry triggering the update. -During the exit interview on 7/23/25 at 9:00 a.m., the Director of Operations acknowledged these findings.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 50523 1. Based on observation, staff interview, medical record review, and a review of the facility’s Policies and Procedures (P&P), it was determined that the Medical Director failed to ensure that one of one Registered Nurse (RN AA) observed, adhered to the facility’s established P&P relative to pre-dialysis assessment of two of two patients (P) (P#2 and P#3), observed. Failure to perform a thorough nursing pre-dialysis assessment such as assessing both patients’ (P#2’s and P#3’s) lung sounds by auscultation (method used to listen to the sounds of the lungs to detect abnormal sounds such as rales, rhonchi, wheezes, or diminished lung sounds using a stethoscope), to help determine P#2’s and P#3’s fluid overload status, (along with their pre-dialysis weight and Estimated Dry Weight [EDW] or target weight), had the potential to incorrectly determine or miscalculate the amount of fluid to be removed during hemodialysis - either removing too much or too little. This deficient practice had the potential to negatively affect the health and safety of P#2 and P#3. The facility census was 10. Findings include: During observation in the Patient Treatment Room on 7/23/25 between 5:00 a.m. and 6:40 a.m., the following was revealed: - P#2 entered the Patient Treatment Room at 5:03 a.m., and hemodialysis treatment was initiated at 5:10 a.m., by Patient Care Technician (PCT) AA, at Station (S) 7. At 5:11 a.m., RN AA was observed while she performed patient assessment. RN AA asked P#2 how she felt, but did not listen to P#2’s lung sounds per facility P&P. - P#3 entered the Patient Treatment Room at 5:07 a.m., and hemodialysis treatment was initiated at 5:15 a.m., by PCT CC at S6. Again, RN AA performed patient assessment at 5:16 a.m. by asking P#3 how he felt, but did not listen to P#3’s lung sounds to assess P#3’s pulmonary status per facility P&P. - P#2’s and P#3’s heart sounds were not assessed for irregular rate and rhythm and murmur either. During an interview on 7/23/25 at 6:29 a.m., RN AA acknowledged the above observation and stated that she relied on her findings from the verbal assessment to determine whether the patient required further evaluation. A review of P#2’s and P#3’s dialysis treatment records dated 7/23/25, showed that P#2’s and P#3’s pre-dialysis assessments were both marked completed and finalized at 5:00 a.m, (which was before P#2 and P#3 even entered the Patient Treatment Room), by RN AA. Additionally, RN AA documented “no abnormal findings”, prior to RN AA’s actual (verbal) assessments of both patients. - A review of facility Policy: (no number), titled, “Monitoring and Care of the Patient on Hemodialysis”, with no effective or revision date, stated: 1. Each patient will have a pre-dialysis assessment to include the following: a. Physical assessment by the RN or LPN (Licensed Practical Nurse) h. Pulmonary- rales, rhonchi, wheezes, diminished sounds. 2. Based on observation, a review of medical records and a review of facility Policies and Procedures (P & P), it was determined that the Medical Director (MD) failed to ensure that five of five patients (P) (P#1, P#2, P#3, P#4, and P#5) sampled, received medical care appropriate to their dialysis needs as evidenced by a lack of a prescription for their dialysis composition of bicarbonate value, for the Direct Patient Care (DPC) Staff (nurses and patient care technicians) to follow during each patient’s hemodialysis treatments. In hemodialysis, bicarbonate is crucial for correcting metabolic acidosis (build up of acid in the blood due to low bicarbonate levels) or metabolic alkalosis (blood is too alkaline due to high levels of bicarbonate), by acting as a buffer to help maintain a healthy acid-base balance in the blood, which is often disrupted in chronic kidney disease. Metabolic acidosis can cause muscle wasting and bone loss, while metabolic alkalosis can increase the risk of hypokalemia (low potassium), hypocalcemia (low calcium), and hemodynamic instability. This deficient practice had the potential risk to negatively affect the health and safety of P#1, P#2, P#3, P#4, and P#5. The facility census was 10 in-center hemodialysis patients. Findings include: During observation in the Patient Treatment Room on 7/23/25 between 5:00 a.m. and 6:40 a.m., the following was revealed: - P#1’s hemodialysis machine showed that the bicarbonate was set at 36 milliequivalents per liter (mEq/L). - P#2’s hemodialysis machine showed that the bicarbonate was set at 37 mEq/L. - P#3’s hemodialysis machine showed that the bicarbonate was set at 38 mEq/L. - P#4’s hemodialysis machine showed that the bicarbonate was set at 38 mEq/L. - P#5’s hemodialysis machine showed that the bicarbonate was set at 32 mEq/L. P#1’s, P#2’s, P#3’s, P#4’s and P#5’s dialysis prescription lacked an order for dialysis composition of bicarbonate value for the DPC staff to follow, when setting up each patient’s hemodialysis machine for treatment. - A review of P#1’s, P#2’s, P#3’s, P#4’s and P#5’s medical records showed the following CO2 (carbon dioxide - blood test to measure bicarbonate levels), results: NOTE: The laboratory’s Reference Range for CO2 was 22.0 - 29.0 mEq/L P#1: - On 3/28/25 - CO2 - 25.0 mEq/L - On 4/16/25 - CO2 - 18.0 mEq/L (L - low) - On 5/5/25 - CO2 - 15.0 mEq/L (L) - On 6/6/25 - CO2 - 17.0 mEq/L (L) - On 7/9/25 - CO2 - 15.0 mEq/L (L) P#2: - On 4/4/25 - CO2 - 24.0 mEq/L - On 5/5/25 - CO2 - 19.0 mEq/L (L) - On 5/9/25 - CO2 - 18.0 mEq/L (L) - On 6/4/25 - CO2 - 1223.0 mEq/L (H - high). There was no documentary evidence of a repeat CO2 blood test to verify validity of very high abnormal result or follow up. - No current CO2 results at the time of this review (7/23/25). P#3: - On 5/7/25 - CO2 - 18.0 mEq/L (L) - On 6/6/25 - CO2 - 17.0 mEq/L (L) - On 7/9/25 - CO2 - 16.0 mEq/L (L) P#4 and P#5 were admitted to this facility on 6/30/25, and their CO2 results were not available at the time of the survey. Note: The ideal range for pre-dialysis bicarbonate levels is often considered to be between 20-22 mEq/L, with a target post-dialysis level around 24 mEq/L. - A review of facility Policy: (no number), titled, “Dialysis Prescription”, (no effective/ revision dates), stated: 1. Prescription Content The dialysis prescription should include (as applicable): “ Dialysate composition (e.g., sodium, calcium, potassium, bicarb) 2. Order Validity and Communication “ Prescriptions must be documented and reviewed regularly by the nephrologist. - During a telephonic interview on 7/23/25 at 12:31 p.m., the Medical Director stated that he did not realize the five sampled patients were missing a prescribed bicarbonate order.”